Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
STUDY TITLE:
A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat
Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine
Transdermal System), 1 mg/24 hr in Healthy Volunteers
TEST DRUG / INVESTIGATIONAL PRODUCT:
Rotigotine Transdermal System, 1 mg/24 hr
INDICATION STUDIED:
Bioequivalence - Irritation and Sensitization
STUDY DESIGN:
- Multiple-site, randomized, multiple-application, evaluator-blinded, controlled study
- One-half (½) of the test patch and one-half (½) of the reference patch was applied daily
to the same site for each product over a 21 day period followed by a rest phase and a
challenge phase